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Aventis Comments that Patent Litigation Has Commenced in Response to ANDA Filing for a Generic Form of Risedronate

Strasbourg, France – Aventis said today that patent infringement litigation has been initiated against Teva Pharmaceuticals USA in response to Teva’s application to market a generic version of Actonel® (risedronate sodium tablets) in the U.S.

Aventis learned in July 2004 that Teva had filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) that included Paragraph IV certifications against several patents for Actonel. Under U.S. law, because patent infringement litigation was initiated within 45 days after receipt of the certification notice, the FDA may not approve marketing of Teva’s proposed generic product until 30 months have elapsed, or until a court decision favorable to Teva is rendered in the litigation, whichever occurs first.

About Risedronate Sodium

Risedronate sodium is a bisphosphonate that is currently approved in 82 countries worldwide. Risedronate 35 mg Once a Week and risedronate 5 mg daily are indicated for the treatment of osteoporosis in postmenopausal women. Risedronate 5 mg also is indicated for the prevention of osteoporosis in postmenopausal women and the management of glucocorticoid-induced osteoporosis (GIO).

In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance

Pierre Perrin-Monlouis
Pierre Perrin-Monlouis
Fondateur de Rente et Patrimoine (cabinet de gestion de patrimoine), Pierre Perrin-Monlouis est un analyste et trader pour compte propre. Il vous fait profiter de son expérience en trading grâce à ses analyses financières et décrypte pour vous les actualités des marchés. Son approche globale des marchés combine à la fois l'analyse technique et l'analyse fondamentale sur l'ensemble des marchés : crypto, forex, actions et matières premières.